Assessment of the efficacy and tolerability of clopidogrel napadisilate in Korean patients with coronary stenting: a multicenter, prospective, open-label, randomized trial. (March 2015)

• Record Type: Journal Article
• Authors: Kim, Sang Hoon; Sung, Jung-Hoon; Shin, Jinho; Lee, Hyun Jong; Lee, Hyun Sang; Cho, Deok Kyu; Lim, Sang Wook
• Is Part Of: Current medical research and opinion. Volume 31:Number 3(2015:Mar.)
• Page Start: 449
• Page End: 457
• Publication Date: 2015-03
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2015.1006726
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>Clopidogrel is indicated for the treatment and prevention of peripheral vascular, cerebrovascular, and coronary artery diseases. This clinical trial was designed to demonstrate that clopidogrel napadisilate (CN) is not inferior to clopidogrel bisulfate (CB) with respect to its effectiveness in inhibiting platelet aggregation.</p> </sec> <sec id="ss2"> <title>Methods:</title> <p>This 4 week multi-center, prospective, open-label, randomized trial was conducted at five clinical centers in South Korea. Patients were randomized into the 75 mg CN group or the 75 mg CB group. Platelet aggregation was assessed by the VerifyNow assay. The primary outcome was the difference of the percentage P2Y<sub>12</sub> inhibition and the secondary outcome was the baseline and change in P2Y<sub>12</sub> reaction units (PRU).</p> </sec> <sec id="ss3"> <title>Results:</title> <p>There was no significant difference in the percentage P2Y<sub>12</sub> inhibition (CN vs. CB, 34.92 ± 21.33% vs. 30.43 ± 17.90%, <italic>p</italic> = 0.203). The mean difference of the percentage P2Y<sub>12</sub> inhibition between groups was 4.49%, their two-sided 95% confidence interval was −2.45% to 11.44%, and the lower bound (−2.45%) was greater than the acceptable non-inferiority margin of −9.0%. The baseline PRU was 96.67 ± 76.76 in the CN group and 216.95 ± 68.86 in the CB group (<italic>p</italic> = 0.121), and the change in the PRU was −3.32 ± 51.71 in the CN group and 10.52 ± 43.31 in the CB group (<italic>p</italic> = 0.106). Four subjects experienced AEs (6.3%, 5 events) in the CN group and 7 subjects (11.11%, 13 events) in the CB group without statistical significance (<italic>p</italic> = 0.364). With respect to serious adverse events, 2 events were reported in 2 subjects, 1 in each group.</p> </sec> <sec id="ss4"> <title>Conclusion:</title> <p>Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability, and there were no clinically significant adverse events.</p> </sec> </abstract>